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Boots 56-90-447 (HEM-7101)

Boots 56-90-447 (HEM-7101)
Device Name:56-90-447
Device Model:HEM-7101
Manufacturer:OBL: Boots, PO Box 5300, Nottingham NG90 1AA, UNITED KINGDOM.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Description: The Boots 56-90-447 (HEM-7101) is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:

While the technology used in the Boots 56-90-447 (HEM-7101), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Previous recommendation, now archivedManufacturer declaration of equivalence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.
 
Consumer BodyVersionQuartileComment
Which? (UK)Previous: 2013B 

Device Family:Boots 56-90-447 (HEM-7101)B, Omron MX3 Plus (HEM-742-E)B (B BIHS Derivative)
Relevant Publications

Ware A, Stevens R, Selwood M, Fleming S. Accuracy of blood pressure monitors available in high street pharmacies. Blood Press Monit. 2016 Feb;21(1):59-61. doi: 10.1097/MBP.0000000000000151. PMID: 26427055.

Measurements from the Boots 5690447 are compared to those from the Omron BPM tester PA-350, though not in a formal validation.

Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Omron MX3 Plus (HEM-742-E)

Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron MX3 Plus oscillometric blood pressure monitoring device according to the European Society of Hypertension international protocol. Blood Press Monit. 2005 Jun;10(3):165-8. PMID: 15923819.

ESH-IP:2002 - Pass General population

Christofaro DG, Casonatto J, Polito MD, Cardoso JR, Fernandes R, Guariglia DA, Gerage AM, de Oliveira AR. Evaluation of the Omron MX3 Plus monitor for blood pressure measurement in adolescents. Eur J Pediatr. 2009 Nov;168(11):1349-54. Epub: 2009 Feb 17. doi: 10.1007/s00431-009-0936-x. PMID: 19221789.

BHS:1993 - Pass (A/A) General population

SP10:1996 - Pass General population